Bone Healing Accelerant (BHA) Versus Autologous Bone Grafting (ABG) for Hindfoot or Ankle Arthrodesis

Carmell Therapeutics

Status and phase

Withdrawn

Phase 2

Conditions

Foot Deformities

Treatments

Combination Product: BHA

Study type

Interventional

Funder types

Industry

Identifiers

NCT06258499

CAR-BHA- U22

Details and patient eligibility

About

This study is being conducted to demonstrate the safety and effectiveness of Bone Healing Accelerant (BHA) product when applied to the joint space of the ankle of hindfoot (the section of the foot immediately below the ankle joint) during fusion surgery. It is hypothesized that by 6 months, the number of subjects with successful bone fusion will be greater in the BHA-treated group compared to subjects treated with standard of care alone.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient has pain with weight-bearing in the joint(s) below that, in the opinion of the Investigator, warrants arthrodesis:
1. Tibiotalar (ankle)
2. Talocalcaneal (subtalar)
3. Talonavicular
4. Calcaneocuboid
5. Double hindfoot (e.g., talonavicular and talocalcaneal joints)
6. Triple hindfoot (subtalar, talonavicular and calcaneocuboid joints
Joint space(s) can, in the opinion of the Investigator, be adequately filled with no more than 9 cc of graft material (BHA or ABG)
Each fused joint can be adequately compressed and rigidly stabilized with plates, screws, staples or a combination thereof. External fixation, percutaneous Kirschner wires or intramedullary rods may not be used.
Patient is willing and able to comply with all study requirements including all postoperative clinical and radiographic evaluations.
If patient is a woman of childbearing bearing potential (not post-menopausal for 12 months or surgically sterile), patient has a urine pregnancy test with a negative result at screening and on the day of surgery, prior to the procedure. These trial participants must commit to adequate birth control through the 52-week follow-up

Exclusion criteria

Skeletally immature patients (i.e., radiographic evidence of open physes), regardless of age
Bone deficit, defect or void requiring a structural graft
Condition requiring intramedullary nailing or external fixation for the arthrodesis
Condition requiring osteotomy or fusion of any midfoot joints.
Prior arthroplasty, arthrodesis, major surgical repair or reconstruction of the index ankle or hindfoot joints.